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Zydus Cadila gets USFDA nod to market Verapamil Hydrochloride Injection

Drug firm Zydus Cadila said it has received final approval from the US health regulator to market Fingolimod capsules and Verapamil Hydrochloride Injection.

Zydus Cadila | USFDA

Press Trust of India  |  New Delhi 


Drug firm on Friday said it has received final approval from the US health regulator to market Fingolimod capsules and Verapamil Hydrochloride Injection.

Fingolimod capsules is indicated for the treatment of patients with relapsing forms of multiple sclerosis. While, Verapamil Hydrochloride Injection, is used to rapidly/temporarily restore normal heartbeats in people with certain heart rhythm disorders.

has received final approval from the United States Food and Drug Administration (USFDA) to marketFingolimod capsules, (Gilenya)in the strengths of 0.5 mg, Zydus Cadila, part of Cadila Healthcare group, said in a regulatory filing.

The company said the drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.

"The company has also received the final approval from the to market Verapamil Hydrochloride Injection USP, 5 mg/2 mL (2.5 mg/mL) and 10 mg/4 mL (2.5 mg/mL), single dose vials (Isoptin Injection)," said.

The injections will be manufactured at the company's manufacturing facility at Jarod, near Vadodara.

The group now has 305 approvals and has so far filed over 390 abbreviated new drug applications since the commencement of the filing process in 2003-04.

Shares of Cadila Healthcare were trading 2.85 per cent higher at Rs 427.45 apiece on BSE.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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First Published: Fri, October 16 2020. 11:24 IST